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The Clinical Laboratory Improvement Amendments of 1988 All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing. A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease. Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials. The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are: Knowledge Materials used in proficiency, quality control, and calibration of materials Features of operational steps Experience and training Troubleshooting of test system troubleshooting and maintenance of equipment Preparation of reagents and other materials Interpreting and judging the results of the tests Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include: Procedure manual A basic part of the Clinical Lab

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Standard Operating Procedures for Clinical Trials: A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. What are standard operating procedures for clinical trials? Standard operating procedures for clinical trials are written instructions that are detailed to provide information about every aspect of the trial. With this set of standard operating procedures for clinical trials, principals seek to bring about a level of uniformity in a particular task of the clinical trial. Consistency in these standard operating procedures for clinical trials has to be ensured so that the clinical trial meets local, state and federal government and global guidelines and requirements. Equally importantly, standard operating procedures for clinical trials have to also meet regulatory guidelines set out by bodies such as the FDA. The purpose of standard operating procedures for clinical trials should be to help the trial achieve consistency in the quality control and quality assurance. In addition, standard operating procedures for clinical trials should be designed to help the trial achieve the quality of auditability. This is because any clinical trial goes through audits from regulatory bodies, making the role of standard operating procedures for clinical trials all the more important. Factors to bear in mind while establishing standard operating procedures for clinical trials: Standard operating procedures for clinical trials should thoroughly document these among other elements: Event Reporting Safety Monitoring Laboratory Management Pharmacy Management Development of Protocols Informed Consent Operations at the site of the clinical trial While these may be considered the core asp

Overview:   Institute for Healthcare Improvement (IHI) defines reliability as "failure-free performance over time2". This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. spite of variability in the patient environment.  This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That is the challenge we need to face and find elegant solutions zero mistakes or find a way to protect patients if a mistake cannot be prevented.  Why should you Attend: The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 400,000 patients die each year from hospital mistakes. Another 2.1 are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. Discussions with doctors show that there is reluctance to apply reliability principles to healthcare systems because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time. But good approaches to improving the system reliability have been tried and tested in many industries. There is a

Up, close, and personal with MIPS Quality reporting. We have some of the measures if not all for the 2020 performance year. Providers, kindly, take a look at them and also give us your feedback.

Up, close, and personal with MIPS Quality reporting. We have some of the measures if not all for the 2020 performance year. Providers, kindly, take a look at them and also give us your feedback.

Up, close, and personal with MIPS Quality reporting. We have some of the measures if not all for the 2020 performance year. Providers, kindly, take a look at them and also give us your feedback.

There is little time left for MIPS 2020 quality reporting. Some of you might have selected quality measures but with this little time, reconsider your choices and consult a MIPS Qualified Registry for guaranteed MIPS quality measures submission.

A reclining wheelchair allows several key parts of the device, including the foot rests and backrest, to be adjusted to accommodate various needs and positions. Reclining wheelchairs are high back wheelchairs that allow the user to recline from a 90 degree position down to 180 degree position. Reclining wheelchairs have handbrake-like controls that release the back and lock it into place. Reclining wheelchairs are equipped with removable full support headrests, swing away elevating leg rests and padded arm rests for additional support and comfort. Like standard wheelchairs, reclining wheelchairs fold compactly for easy transport and storage. Different Types Of Reclining Wheelchairs: Reclining Wheelchair 902 GC Reclining Wheelchair 609 GC Karma Aurora 4 Reclining Wheelchair Karma Reclining Wheelchair KM 5000 Karma VIP 515 Wheelchair Reclining backrests can be a useful feature for children: Are unable to sit upright for sustained periods because of weak muscles in the upper body, or a stiff spine or hip. Have difficulty breathing. Are receiving treatment that require them to be in a reclined position. Karma Aurora 4 Reclining Wheelchair: Frame Style : Fordable Frame Material : Aluminium (Light weight) Seat Width (inches) : 18" Total width in wheel to wheel : 11" Rear Wheel Size : 24" Front Wheel Size : 7" Seat to floor height (inches) : 20" Seat Depth (inches) : 16" Back height (inches) : 35" Total height (inches) : 50" Max User Weight Capacity (kgs) : 120 Net Weight (kgs) : 13.5 k.g. Upholstery : Cloth water-proof. Armrest : Detachable, for easy transfer to bed. Leg-rest : Detachable, can also be elevated & with calf support for added comfort Wheel Quality : MAG WHEEL Rear Wheel Brakes : Available Hand brakes : Available Reclining Wheelchair Features: Lightweight aluminum wheelchair. Double crossbraces for extra strength. Folding frame. Padded detachable armrests with side panels. Length-adjustable leg supports. Punctu

This program has combined previous quality reporting programs such as Physician Quality Reporting System (PQRS), Value-based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive program (Meaningful Use) under one platform.

This program has combined previous quality reporting programs such as Physician Quality Reporting System (PQRS), Value-based Payment Modifier (VM), and the Electronic Health Records (EHR) Incentive program (Meaningful Use) under one platform.

We found that the MIPS 2020 and MIPS 2019 Quality measures are more similar than they are different. Nevertheless, we got into a bit of detail in this article to give you a better idea.

In MIPS 2019 and MIPS 2020, participants get to submit 6 quality measures data for 12 months (from January 1 to December 31, 2019, and January 1 to December 31, 2020, respectively). The amount of data to undergo submission depends on the collection (measure) type.

CMS has come up with practical solutions for the healthcare industry; it has constantly fought against the burnout epidemic by reducing reporting requirements. We, as a MIPS Qualified Registry, appreciate their efforts and of their administrator, Ms. Seema Verma.

Ms. Seema Verma lays out the plan to enhance quality in healthcare in the 2020 CMS Quality Conference. For the plan to execute in a meaningful way, the article discusses the chapter of strategy and implementation comprehensively.

Overview: This presentation will introduce the participants to changing role of the panoramic x-ray machine in dental offices today. Its expanding role in extra oral exposures and enhanced diagnostic capabilities is forever changing the path of dental x-ray imaging. Digital radiography is rapidly improving in diagnostic quality and loweringthe radiation exposure with ultra-low dose technology. We can have extra oral 2D bite wings and periapical x-rays with less radiation and greater diagnostic capability than traditional intraoral x-rays. The time has come that all dentists should have access to 3D-Cone Beam Computer Tomography. It is rapidly becoming the standard of care. Why should you Attend: Digital radiography is rapidly changing in today's dental offices. The new technology is revolutionizing patient flow and improving diagnosis. Dr. Jesek is at the forefront of this technology, using both 2D and 3D radiography. Seminar attendees will get easy to understand approach, which enables deep learning and provides tools they can use when they get back to the office Monday morning. Areas Covered in the Session: CBCT can be used to in areas of general dentistry to improve patient acceptance and quality of treatment outcomes. General and Restorative Dentistry Oral Surgery Implant Dentistry Endodontics Periodontics Orthodontics Sleep Apnea/Air way Who Will Benefit: Dentists Hygienists Assistants Speaker Profile : Dr. Warren Jesek graduated from Millikin University with a B.A. in biology and chemistry. After, he completed graduate work studies in anatomy at the University of Nebraska before attending Loyola University Dental School where he received his dental degree in 1979. He has maintained a private general practice in Decatur, Illinois since 1979. Unique to the area, his practice houses a crown and bridge laboratory with three technicians focusing on CAD/CAM milling technology to produce metal-free inlays, crowns and bridges. Dr. Jesek continued his training

Overview: The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws. Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities. Areas Covered in the Session: Trial Master File (TMF): what is it? Essential documents required ICH guidelines and Good Clinical Practice (GCP) Food and Drug Administration (FDA) guidance and expectations Paper or electronic trial master files - what is allowable Links to useful resources Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator positions (1-2 years) New Principal Investigator positions Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme

The emerging discipline of Hospitals Management Performance Assessments Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics to evaluate the critical functioning levels of hospitals. The topic of Hospitals Management Performance Assessments came to acquire proper shape and structure following the heavy reference the WHO made to this discipline at the WHO European Ministerial Conference on Health Systems of June 2008. The following year, it found resonance again, when it was the theme of the World Health Day. The evaluation of Hospitals Management Performance Assessments Hospitals Management Performance Assessments started to evolve primarily to provide healthcare professionals with a tool to diagnose the quality of performance of the hospitals and other healthcare settings they work in. It was felt, over time and experience, that when strict appraisals were being made in many areas of healthcare, a set of parameters to assess the level of efficiency of hospitals would go a long way in ensuring the implementation of enhanced processes, leading to better patient outcomes. Areas of concentration for Hospitals Management Performance Assessments The core disciplines in which Hospitals Management Performance Assessments sought to bring about measurable and verifiable improvements were: The PATH approach As a result of discussions and deliberations the WHO held with many countries, primarily European, a path for charting out the course of Hospitals Management Performance Assessments was concretized in the form of what the WHO called the PATH - the Performance Assessment Tool for Quality Improvement in Hospitals. A brief understanding of PATH PATH

Tynor Wrist Brace with Double Lock is designed with a double lock that will make it simple to apply and remove. Its double lock feature gives rigid support to the wrist. It partially keeps the wrist immobilized. It can easily adjust the compression around the affected area as per the desire. It provides the warming feel to the injured area to allay the local pain and inflammation. It has a high modulus of elasticity which works for a long time, even if use this on a regularl basis. It has striped elastic webbing which is of high quality material. This double lock wrist brace is strong, rigid and comfortable to wear. Its material is porous in nature which keeps the affected area air ventilated. It can adjust the compression pressure according to the will. Its double hook loop locking system is easy to apply and remove as well as comes with universal sizing. This wrist brace provides strength and support to the wrist and keep the wrist protected against the further injury or damage. Tynor Wrist Brace with Double Lock Wrist brace with double lock is designed to support, protect and partially immobilize the wrist. It compresses the area and retain the body heat to allay local pain and inflammation. Extra grip. Extra porous Controlled compression. Easy application. Tynor Wrist Brace with Double Lock Features High quality, striped elastic webbing Strong and durable Porous and comfortable High modulus of elasticity- Retains shape and size for a long time. Excellent compressive strength, better support Hook loop Double locking Easy to apply and remove Ensures optimal compression Better fitting and universal sizing. Tynor Elbow Support Elbow support provides firm compression, warmth & support to the forearm and the elbow joint, to allay pain inflammation and stiffness, generally associated with old age, arthritis, sports injury etc. Light weight Four way stretch Freely breathable Soft and comfortable Tynor Elbow Support Features Anatom

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Wheeled platforms with specially-molded seating systems interfaced with them for users with a more complicated posture. A molded seating system involves taking a cast of a person's best achievable seated position and the either carving the shape from memory foam or forming a plastic mesh around it. This seat is then covered, framed, and attached to a wheelbase this becomes more of a custom wheelchair then a standard type. Heavy Duty/High Weight Capacity is a collection of mobility products with expanded maximum weight capacities. Heavy duty wheelchairs, bariatric scooters and more, combined with an expert staff. Heavy duty/high weight capacity wheelchairs feature additional crossbraces for support and heavy duty/high weight capacity electric mobility products have stronger motors to accommodate a higher weight. Heavy Duty manual wheelchairs have a reinforced heavy-duty frame that accommodates weight capacities ranging anywhere from maximum weight depending on the chair. Heavy Duty Wheelchair is strongly constructed and offers a high degree of comfort to larger users. As expect from a wheelchair of this quality, the detachable footrests swing away, the armrests flip back, and the backrest can be folded. The frame is as compact as possible whilst still allowing a wide, comfortable seat (available in 20 or 22" seat sizes), and the extra-wide castors are designed to meet the demands of heavy use. Heavy Duty is a quality option for anyone for a self-propelbariatric wheelchair. Karma 8520 Heavy Duty Wheelchair: It comes with detachable swing away footrests. The wheel chair has flip-back armrests. It comes with centre of gravity adjustment. The wheel chair has wide profile casters. Seat Size 20'' inch & 22'' inch Total Weight 17 K.G. Features : Foldable, lightweight frame for easy portability. Steel double cross-brace frame. Adjustable-tension back upholstery. Armrests are padded, adjustable and removable. Adjustable-length controller mount. Adju

Bronco Wheelchair: Bronco Reclining Power Wheelchair Description: Comfort mobility is a professional Bronco Wheelchair and power scooter manufacturer established in 1978 in Taiwan. It operates with the policy of combining high quality with innovation. With dedication to research and development, Bronco wheelchair are exported around the world and earned solid reputation for its superior quality, comfort and convenience. Bronco wheelchair - comfortable, durable, designed for easy and healthy movement with full precautions. Bronco Reclining Power Wheelchair Specifications: Anchorage points Adjustable footplates LED front lights Detachable backrest Flip-back armrests Adjustable headrest Mechanic repairs Optional handbrake

Transport wheelchairs are machines or equipment that facilitate for mobility and movement of wheelchair confined people at public places. While it is true that simple wheelchairs can do the trick, travel Wheelchair are specifically designed and manufactured to facilitate better roaming and mobility at malls, restaurants and parks where people usually converge to relax. A seat belt and swing-away removable footrests are standard and make it easy to get in and out of this chair. A fold-down back allows for easier storage and transport and padded armrests add additional comfort. The materials with which travel Wheelchair are made are of more superior quality and strength. That is because Travel Wheelchair are made very specifically to facilitate movement at public and outdoor places. Also, travel Wheelchair are made of materials that are highly durable to enable it to carry out its purpose. Thus, it is often that users complain about the limited usefulness and comfort of using the wheelchairs. Karma Travel Wheelchair KM TV 20.2: Karma Travel Wheelchair KM TV 20.2 - 606 T-6 aircraft-grade aluminum-alloy frame provides incredible strength. Easy-to-fold in three seconds. Karma Travel Wheelchair KM TV 20.2 Features: Type: Travel Wheelchair T-6 aircraft-grade aluminum Secure brake improve safety Padded flip back armrest PU front caster & rear wheel Karma Travel Wheelchair KM TV 20.2 Measurements: Weight: 8.9kg Seat width: 39.5cm Tyre: PU front casters and rear wheels Capacity: 100kg Folded size: (L/W/H): 610mm x 350mm x710mm. Ultra Lightweight Wheelchair: Its compact design and feather light weight makes it suitable for people on the go. Ultra Lightweight Wheelchair Specifications: Frame Style : Foldable Frame Material : Aluminium (Light weight) Rear wheel to wheel width in open position (inches) : 20" Handle to Handle : 16" Seat Width (inches): 13" Rear Wheel Size: 7" Front Wheel Size: 5" Seat to floor height (inches): 19" Seat Dep

Tynor Wrist Brace with Thumb is created to reinforce, prevent and partially immobilize the wrist and the palm. This wrist brace allows natural and free activity of the fingers. It keeps the affected area compact and maintains the body heat to lessen the local pain inflammation. Its has high quality striped elastic webbing which provides high modulus of elasticity which gives the comfortable feel. It is made from the strong, durable, porous and a comfortable material which remains for a long time. This Wrist Brace provides excellent compressive strength and support to the wrist. Its Hook loop closures allow easy application and removal. It fits comfortably around the wrist and comes in universal sizing. It also has an anatomical thumb opening which fastens the healing process. It keeps the thumb in relaxed and comfortable position. Its extra porous material allows the proper ventilation to the affected skin. Tynor Wrist Brace with Thumb Wrist brace with thumb is designed to support, protect and partially immobilize the wrist and the palm while allowing free and natural movement of the fingers. It compresses the area and retains the body heat to allay local pain and inflammation. Extra grip. Extra porous Controlled compression. Anatomical thumb placement. Tynor Wrist Brace with Thumb Features High quality , striped elastic webbing Strong and durable Porous and comfortable High modulus of elasticity- Retains shape and size for a long time. Excellent compressive strength, better support Hook loop closures Easy to apply and remove Ensures optimal compression Better fitting and universal sizing. Anatomical thumb opening Better pain relief and healing. Thumb in abduction remains relaxed, no fatigue Improves comfort Allows free and natural movement of the thumb and fingers. Tynor Tennis Elbow Support Tennis Elbow Support is designed to help provide relief from generalized pain and tenderness in the forearm and elbow caused by repetitiv

Overview:   Review 6 points of high quality evidence based clinical documentation Review of 7 criteria that all entries in a patient record should include Impact of documentation on coding and claims Impact on audits and ability to defend an audit When an audit is initiated, the completeness of documentation becomes critical in the ability to support what you have reported. Let's take a look at areas in which weaknesses are often found.  Why should you Attend:  The granularity and accuracy of the ICD-10 code set is supported by quality clinical documentation. It is anticipated that payers will increasingly become less flexible in allowing non-specific codes. The use of unspecified codes will likely lead to rejected claims if it is possible to report the more definitive condition. In most cases, unspecified should not be reported unless there is clear evidence to support the inability to report the detailed option.  Is your E & M level supported in the documentation? If you have never experienced scrutiny of your billing patterns by payers and other entities, you may not be aware of weaknesses that lead to recovery of funds or other costly consequences. Your documentation will be key in supporting diagnoses, service codes and acuity of the patient. It is not just payers who engage in audits. Others include State medical boards, Qui Tam and possible reporting of questionable practices by patients. Do your billing patterns and documentation stand up under reporting scrutiny? This presentation will review areas in which you may not be as strong as you think!  Areas Covered in the Session: Significance of abnormal lab results Measurement of lesions, when taken and inclusion of margins Start & stop times & methodology for infusions & discrepancies in billing Diagnostic testing and medications should be supported in a diagnosis Depth of wounds and cause should be clear Severity of illness Diagnosis present on admission? Who Will Benefit: Coders Billers Rev